VestibularFirst Insight Infrared Video Goggles User manual

Date of Issue: 2020-10-06User Manual Version: 1.2
Insight Infrared Video Goggles
VestibularFirst.com

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Thank you for investing in quality care for vestibular patient care and education
by adding Insight Infrared Video Goggles to your practice.This user manual
will cover contraindications, safety warnings, cautions, recommendations
for use, storage, care of the goggles, and contact information for the
manufacturer. If you have questions, please reach out to our team:
• Visit us online at VestibularFirst.com/Support
• Email us at [e-mail]
• Call us at [phone]
Federal law restricts the sale, distribution or use of the system to,
by, or on the order of a licensed medical practitioner.

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1 . Introduction ................................................................................................................................ 3
1.1. Contact Information .................................................................................................................. 3
1.2. Indications of Use....................................................................................................................... 3
1.3. Product Description ................................................................................................................... 3
1.4. Computer Requirements........................................................................................................... 4
1.5. Safety Classification and Regulations...................................................................................... 5
1.6. Transport, Storage, and Use....................................................................................................... 12
1.7. Contraindications,Warnings, Cautions, and Recommendations ......................................... 13
1.8. Markings and Storage............................................................................................................... 18
1.9. Packaging inspection and shipping box ................................................................................ 20
1.10. Inspecting for and reporting damage to the goggles........................................................... 20
2. System Overview ........................................................................................................................ 21
2.1. Modular Goggles....................................................................................................................... 21
2.2. Software ...................................................................................................................................... 24
3 . Software Installation & Configuration....................................................................................... 27
3.1. Installation .................................................................................................................................. 27
3.2. OBS Configuration ..................................................................................................................... 29
3.3. Scene Collection Templates...................................................................................................... 34
4. Using the Insight Infrared Video Goggles ................................................................................ 35
4.1. Initial Setup & Checks................................................................................................................ 35
4.2. Cleaning the Goggles............................................................................................................... 36
4.3. Considerations Prior to a Patient Donning Goggles ............................................................... 38
4.4. Donning the Goggles................................................................................................................ 38
4.5. Centering the Eyes..................................................................................................................... 41
4.6. Select Additional Scenes........................................................................................................... 42
4.7. Starting & Stopping Video Recording ...................................................................................... 45
4.8. How to Use the Visual Fixation Light.......................................................................................... 45
4.9. How to Remove and Attach the Camera Unit......................................................................... 46
4.10. Doffing the Goggles................................................................................................................... 48
4.11. Accessing and viewing recorded videos ................................................................................ 48
4.12. Accessing and viewing recorded videos ................................................................................ 49
4.13. Cleaning and Storing Your Goggles ........................................................................................ 49
5. Troubleshooting, Repair, and Warranty..................................................................................... 50
5.1. Goggles Troubleshooting .......................................................................................................... 50
5.2. Software Troubleshooting .......................................................................................................... 52
5.3. Warranty and Repairs ................................................................................................................ 54
5.4. Contact Information .................................................................................................................. 54
Table of Contents

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1.1. CONTACT INFORMATION
This manual is valid for the Insight Infrared Video Goggles.
The manufacturer Vestibular First is located at:
9 Mather Ave
Broomall, PA, 19008
United States
They can be contacted at:
Online: VestibularFirst.com/support
Email : support@vestibularfirst.com
Phone: [phone]
The country of origin is the United States of America
1.2. INDICATIONS OF USE
The Insight Infrared Video Goggles are intended for viewing and recording eye
movements in support of identifying vestibular disorders in patients.The device
is intended for use only by a trained healthcare professional in an appropriate
healthcare setting.This device provides no diagnoses nor does it provide
diagnostic recommendations.The target population is 12+ years of age.
1.3. PRODUCT DESCRIPTION
The system consists of a head-mounted goggles made up of modular units including
a body unit, removable front cover (camera unit), two infrared video cameras inside
the camera unit, cable with two USB connectors, and an off-the-shelf (OTS) video
viewing software application running on a clinician-supplied computer.The Insight
Infrared Video goggles are designed to be used by clinicians to visualize and record
eye movements with and without fixation.These goggles can be used wherever a
clinician may need to examine a patient, including but not limited to hospitals, rehab
facilities, outpatient clinics, urgent care centers, and patients’ home environments.
1. Introduction

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The goggles are placed on the patient’s head with the cameras facing the patient’s
eyes.The cameras illuminated with infrared light transmits a video signal of the eye
movements to the computer screen for display.The computer uses an off-the-shelf
video software Open Broadcaster Software (OBS) to allow for viewing and recording.
INCLUDED PARTS
• Insight Infrared Video Goggles
• Travel Case
• Quick-Start Guide
OUR GOGGLES SUPPORT CLINICIANS PERFORMING THE FOLLOWING TESTS:
• Spontaneous Nystagmus
• Gaze-Evoked Nystagmus (Gaze Test)
• Horizontal Head Shake Test
• Vertical Head Shake Test
• Vibration Induced Nystagmus Test
• Hyperventilation Test
• Pressure (Fistula) Test
• Dix Hallpike Positional Test
• Roll Positional Test
• Side Lying Positional Test
• Pupillary Response to Light
1.4. COMPUTER REQUIREMENTS
MINIMUM HARDWARE REQUIREMENTS
• i5 processor or better
• Minimum 8 GB RAM or more
• Hard drive with minimum 64 GB free space
• Two (2) USB 2.0 ports are required or a USB hub can be used in a
single USB 2.0 port for the system to perform as intended
• Minimum display of 800x600 (higher resolution recommended)

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• Dedicated video card (optional, but strongly recommended)
OPERATING SYSTEM REQUIREMENTS
• Microsoft - Windows 10 or later
• Apple - MacOS 10.12 Sierra or later
1.5. SAFETY CLASSIFICATION AND REGULATIONS
SAFETY CLASSIFICATION
• Protection against electric shock: Determined by the electric
shock protection type of the computer connected to the USB
• Classification of applied part: Type BF applied part (cushion)
• Method(s) of sterilization: No requirement for sterilization
• Protection against harmful ingress of water or particulate matter: IP20
• Mode of operation: Continuous
• Suitable for use in an oxygen rich environment: No
STANDARDS
The Insight Video Goggles complies with the following standards:
• IEC 60601-1: Medical Electrical Equipment. Part 1: General requirements for safety
• IEC 60601-1-2: Medical Electrical Equipment. Part 2: Electrical Safety
• IEC 62471-1: Photobiological safety of lamps and lamp systems
• ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation
and Testing Within a Risk Management Process. (Biocompatibility)
• ISO 10993-10: Biological evaluation of medical devices -
part 10: tests for irritation and skin sensitization
• ISO 10993-5: Biological evaluation of medical devices
- part 5: tests for in vitro cytotoxicity
External equipment intended for connection to USB complies with the applicable
standards of the IEC 60601 series. In addition, all such combinations of systems
comply with the IEC 60601-1 safety requirements for medical electrical systems.
Any person who connects external equipment to USB has formed a system and is
therefore responsible for the system to comply with the requirements of IEC 60601-1.
If in doubt, contact a qualified technician or the manufacturer’s representative.

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ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidance and manufacturer´s declaration – electromagnetic emission –
for all EQUIPMENT AND SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic emission
The model Insight Infrared Video Goggles is intended for use in the electromagnetic
environment specified below.The customer or the user of the model Insight Infrared Video
Goggles should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The Model Insight Infrared Video Goggles uses RF
energy only for its internal function.Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
The Model Insight Infrared Video Goggles is
suitable for use in all establishments, including
domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fluctuations
/flicker emissions
IEC 61000-3-3
Not applicable

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Guidance and manufacturer’s declaration – electromagnetic immunity – for all
EQUIPMENT and SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic immunity
The Model Insight Infrared Video Goggles are intended for use in the electromagnetic
environment specified below.The customer or the user of the Model Insight Infrared Video
Goggles should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level
Electromagnetic
environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
± 8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Radiated RF
Immunity IEC
61000-4-3
10 V/m 10 V/m N/A
Electrostatic
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
100 kHz repetition
frequency
± 1 kV for input/
output lines
N/A N/A
Surge
IEC 61000-4-5
± 0.5 kV, ± 1 kV
differential mode
line-line
N/A N/A
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0 % UT
(100 % dip in UT )
for 0.5 cycle at 0°, 45°,
90°, 135°,180°, 225°,
270°, and 315°
0 % UT
(100 % dip in UT )
for 1 cycle at 0°
70 % UT
(30 % dip in UT )
for 25/30 cycles at 0°
N/A N/A
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m, 50/60Hz 30 A/m, 50/60Hz
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Note: UT is the a. c. mains voltage prior to application of the test level.

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Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY
Guidance and manufacturer’s declaration – electromagnetic immunity
The Insight Infrared Video Goggles is intended for use in the electromagnetic environment
specified below.The customer or the user of the Insight Infrared Video Goggles should assure
that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80
MHz
6 Vrms 150
kHz to 80
MHz outside
ISM bandsa
N/A
Portable and mobile RF communications
equipment should be used no closer to
any part of the Models Insight Infrared
Video Goggles, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation
distance
where P is the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and d is
the recommended separation distance in
metres(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
ashould be less than the compliance level in
each frequency range b
Interference may occur in the vicinity of
equipment marked with the following symbol:
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.7
GHz
10 V/m
Note 1:At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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Guidance and manufacturer’s declaration – electromagnetic immunity
a:The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz
to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.The
amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz
to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0
MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
b:The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas. For this reason,
an additional factor of 10/3 has been incorporated into the formulae used in calculating the
recommended separation distance for transmitters in these frequency ranges.
c: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio,AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy.To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Insight Infrared Video Goggles is used exceeds the applicable RF compliance level
above, the Insight Infrared Video Goggles should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Insight Infrared Video Goggles.
d: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.